NCT03686280

Resume Walking by an Interactive Mobile Robot of Rehabilitation After Vascular Stroke (Cerebral Vascular Stroke) in Combination With Traditional Reeducation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The recovery of a balance and gait is a primary objective for geriatric, neurological or orthopedic rehabilitation. Since the 80s, many walking robots were proposed. Despite encouraging results, the use of robotic equipment for gait training remains limited, even if they meet a strong social demand. The reasons for this situation are economic, but also related to the non consideration of the context of utilization . This project aimed at developping a mobile and interactive robot, dedicated to the rehabilitation of balance and gait at an early stage. It was intended for patients with impaired walking vascular neurological, traumatic or associated with chronic neurological disease. The aim of the study is to study the effectiveness of the prototype (interactive walking mobile robot).

Conditions

• Stroke Sequelae

Interventions

Type	Name	Description
OTHER	Clinical evaluation	A clinical evaluation of the balance and the walk: is carried out by one of the coordinating physiotherapists of the center where the patient realizes his rehabilitation. The latter performs, according to the functional level of the patient, the following tests: Berg balance scale, FAC, PASS, TUG, 10MWT, 6MWT, paretic lower limb traction index , LBA, SSA and SSV, measurement of spasticity and sensitivity(D0, D30 and D90)
OTHER	Intervention - with Robot	16 sessions of 45 minutes of reeducation with robot of the walk and the procedure to follow with the same patient for the same phase of rehabilitation of the balance and the walk or of several of them (Annex 3b), at the rate of 3 at 5 sessions per week, for 4 weeks and according to predefined exercises
OTHER	Intervention - without Robot	16 sessions of 45 minutes of reeducation without robot of the walk and the procedure to follow with the same patient for the same phase of rehabilitation of the balance and the walk or of several of them (Annex 3b), at the rate of 3 at 5 sessions per week, for 4 weeks and according to predefined exercises
OTHER	quality of life assessment	A quality of life assessment: SIS questionnaire completed by the patient, the results of which will be reported in the observation book by the coordinating physiotherapist who carried out the evaluations described above. (D0, D30 and D90)
OTHER	An assessment of patient acceptance of robotic rehabilitation	An assessment of patient acceptance of robotic rehabilitation (for patients in the robot group): self-questionnaire to be filled in by the patient (before carrying out the gait tests in order to avoid influence the results) (D30 ans D90)
OTHER	cognitive assessment	An evaluation of cognitive functions (between D0 and D30): research dysexual cognitive-behavioural syndrome, hemineglect visio-spatial, memory disorders. Done by a doctor evaluator.
OTHER	An evaluation of how to use the robot	An evaluation of the robot's modalities of use (for patients in the robot group): time of use, distance travelled, walking speed, exercise duration, percentage of regulated suspension, number of breaks, average length of breaks, total length of breaks. (D30)

Timeline

• Start date: 2021-01-13
• Primary completion: 2023-04-01
• Completion: 2023-07-01
• First posted: 2018-09-26
• Last updated: 2021-04-29

Locations

2 sites across 1 country: France